Kornimate/medical-research-clean huggingface dataset:
the exploratory clinical trials on the primary safety and effectiveness of high myopic posterior scleral fixation system

Conditions: High Myopia; Macular Schisis

Summary: the purpose of this study is to assess the primary safety and efficacy of high myopic posterior scleral fixation system in the treatment of macular schisis caused by high myopia.

posterior scleral reinforcement（psr） is the only surgical method that can delay the the development of high myopia. however, the surgical method is restricted by the material source limitation and macular ischemia in the eye after reinforcement. the investigators have designed a new posterior scleral fixation system，its basic material is medical silicone，the product is designed to solve the problem of material source limitation and macular ischemia in the eye after reinforcement.

Eligibility criteria:
inclusion criteria: 1. age 18\~65, male or female; 2. refractive ranges from -6.00d to -25.00d; 3. the axial length of the operative eye was 26-32mm; 4. macular cleavage 200-1000μm; 5. corrected visual acuity of the operative eye \< 0.3; 6. able to understand the purpose of the test, voluntarily participate and sign the informed consent form. exclusion criteria: 1. known allergy to silica gel and patients with scar constitution; 2. ocular inflammation; 3. fundus hemorrhage; 4. macular hole; 5. macular cleavage of the contralateral eye greater than 200μm; 6. corrected visual acuity of contralateral eye \< 0.4; 7. opacity of the refractive medium; 8. eye tumor; 9. history of hyperthyroidism; 10. other ophthalmic concomitant diseases that cannot be controlled, such as diabetic retinopathy, hypertensive fundus lesions, optic nerve atrophy, etc.; 11. severe impairment of liver and kidney function and/or severe systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc., depending on the tolerance of surgery); 12. women who are pregnant (determined by a blood pregnancy test at the first visit), who are preparing for pregnancy during the test, and who are breastfeeding; 13. a history of drug abuse or alcohol abuse; 14. participate in other drug or medical device clinical trials within 30 days prior to the screening of this clinical trial; 15. any condition of the subject that the study physician considers to be an impediment to the clinical trial (e.g. subject's susceptibility to mental stress, uncontrollable mood, depression, etc.); 16. poor compliance of the subject, unable to complete the test process as required.

Keywords: posterior scleral reinforcement macular ischemia
a open label extension study for subjects that complete study mp-101-cl-001

Conditions: Short Bowel Syndrome; Short Gut Syndrome; SBS; Short Gut

Summary: mp-101 will be evaluated in this study to see if it is safe and tolerable.


Eligibility criteria:
inclusion criteria: * be male or female adults, 18 years of age or older * have sbs that is inadequately controlled on current antidiarrheal medication (e.g., loperamide or diphenoxylate), including subjects with ileostomies * must have been deemed a completer of study protocol mp-101-cl-001. * males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. postmenopausal is defined as at least 12 months of natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy) * females of childbearing potential must agree to use 1 of the following acceptable birth control methods: * surgically sterile (hysterectomy or bilateral oophorectomy) * surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation) * intrauterine device (iud) in place for at least 3 months * abstinence (not having sexual intercourse) * barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion * stable hormonal contraceptive for at least 3 months prior to study and through study completion * vasectomized partner * females of childbearing potential must have a negative serum human chorionic gonadotropin (hcg) pregnancy test at visit 1. * be able to understand and provide signed informed consent exclusion criteria: * have any history of or active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease that is considered clinically significant, is not currently controlled by medication, and is stable as deemed by the investigator * are currently taking antibiotics for bacterial overgrowth * have known or suspected pregnancy, planned pregnancy, or lactation * have a planned surgery during the course of the study * have a condition the investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk

Keywords: short bowel syndrome sbs chronic diarrhea short bowel short gut short gut syndrome anti-diarrheal opium tincture loperamide diphenoxylate ileostomies tincture of opium dto codeine morphine opiate
precedex versus propofol-awakening for reducing brain injury expansion

Conditions: Brain Injury; Intracranial Pressure

Summary: the purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.

the hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.

Eligibility criteria:
inclusion criteria: * primary diagnosis of traumatic brain injury (tbi), subarachnoid hemorrhage (sah),intracranial hemorrhage (ich), stroke * must require (be on) mechanical ventilation * must require (have in place) intracranial pressure (icp) monitoring * must require (be receiving) continuous iv sedation exclusion criteria: * bleeding diathesis * glasgow coma scale (gcs) \< 5 with fixed pupils * pregnant * elevated icp that requires deep sedation * pulmonary instability * hx of ethanol(etoh) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex * status epilepticus * current neuromuscular blockade

Keywords: brain injury
antidiabetic properties of rose hip

Conditions: Obesity

Summary: the purpose of this study is to determine whether daily intake of a drink containing rose hip powder reduces risk markers of type diabetes and cardiovascular disease.


Eligibility criteria:
inclusion criteria: * bmi \> 30 * willingness to participate in the study * willingness to comply with the daily intake of drinks and the recommended energy intake during the course of the study exclusion criteria: * diabetes * previous or ongoing insulin treatment * abnormal thyroid status * abnormal liver status * abnormal kidney status * known gastrointestinal disorder * pregnancy * suspected allergy to ingredients of the drinks

Keywords: obesity glucose intolerance cholesterol blood pressure
consistency study of three lots of henogen's adjuvanted hepatitis b vaccine when given in 0, 1 month schedule

Conditions: Hepatitis B

Summary: the study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis b with currently available commercial vaccines (target population). this study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.

double-blind, randomised, single centre study with three groups receiving three different lots of henogen's adjuvanted hepatitis b vaccine according to 0, 1 months schedule. blood samples will be taken at month 0, months 1 and 2.

Eligibility criteria:
inclusion criteria: * a healthy male or female adult aged between 18 and 40 years. * written informed consent obtained from the subject exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose. * concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device). * history of hepatitis b infection. * known exposure to hepatitis b virus within 6 months. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: consistency immunogenicity
decitabine for myelodysplastic syndromes and acute myeloid leukemia before allogeneic hematopoietic cell transplantation

Conditions: Higher-risk Myelodysplastic Syndrome; Relapsed /Refractory Acute Myeloid Leukemia

Summary: allogeneic stem cell transplantation (sct) is the only potentially curative therapy for patients with myelodysplastic syndrome (mds) and acute myeloblastic leukemia (aml). relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (hct) in patients，so that there is the need to continue to look for alternative therapies. decitabine, is known to inhibit dna methyltransferase which results in dna hypomethylation and expression of silenced genes including those involved in apoptosis. the approval of decitabine for the treatment of mds and aml has provided an alternative strategy to inhibit disease progression in transplant-eligible patients. to assess the effect of pretransplant decitabine treatment on post transplant outcomes, we recently reviewed our institutional experience with mds and aml patients.


Eligibility criteria:
inclusion criteria: * age 8- 65 years * diseases must be myelodysplastic syndrome and acute myelocytic leukemia * must need a bone marrow transplant * must have the ability to observe the efficacy and events * patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed exclusion criteria: * must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements * must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a category d agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study * must not have a known or suspected hypersensitivity to decitabine

Keywords: myelodysplastic syndrome higher-risk acute myeloid leukemia relapsed /refractory decitabine hematopoietic cell transplantation bridge therapy
single incision laparoscopy

Conditions: Appendicitis; Cholelithiasis; Malignant Hypertension

Summary: laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).


Eligibility criteria:
inclusion criteria: 1. ages 18-75 2. patient has consented for a laparoscopic operation (independent of study participation) 3. attending surgeon decides operation can be completed via a single incision laparoscopic approach exclusion criteria: 1. patients with bmi greater than 40 2. minors and cognitively impaired individuals 3. patients who are asa class iv - illness that is a constant threat to life 4. patients with ascites or child's class c of liver failure 5. patients with known common bile duct stones 6. patients with coagulopathy, abnormal coagulation studies, or who take heparin, coumadin, plavix (clopidogrel), aspirin, or other medication for the purpose of anti-coagulation and cannot be removed from the medication prior to the operation. 7. patients who present with incarcerated (irreducible) or strangulated hernias 8. patients with preoperative hematocrits less than 25. 9. preoperative hematocrit less than 25. 10. patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80. 11. heart rate greater than 130 or less than 50. respiratory rate greater than 35 or less than 6. patients who are on continuous pressor drip for blood pressure support. 12. patients who present for emergency adrenalectomy. 13. patients with ct scan evidence of an abdominal abscess. 14. patients who present 48 hours after the onset of abdominal pain (appendectomy patients)

Keywords: appendectomy cholecystectomy gastric banding adrenalectomy gastric lap-band placement
study to assess rifaximin soluble solid dispersion (ssd) for the delay of encephalopathy decompensation in cirrhosis

Conditions: Hepatic Encephalopathy

Summary: study rnlc3131 is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin ssd-40mg ir for the delay of the first episode of overt hepatic encephalopathy (ohe) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.


Eligibility criteria:
key inclusion criteria: * diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past). * conn (west haven criteria) score of \< 2. * mini-mental state examination (mmse) score \> 24 at screening. * ≥ 18 and ≤ 85 years of age. key exclusion criteria: * active covid-19 that is unresolved * history of sbp * history of evb or aki-hrs within 6 months * history of ohe episode (conn score ≥ 2)
a study of su011248 as therapy in patients with locally advanced or metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to find out if su011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic non small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically proven nsclc * stage iiib (locally advanced with malignant effusion) or stage iv disease * no prior therapy for nsclc * evidence of unidimensionally measurable disease exclusion criteria: * previous treatment with systemic chemotherapy for lung cancer * history of or known brain metastases * nci ctcae grade 3 hemorrhage within 4 weeks of starting study treatment * evidence of hemoptysis within 4 weeks of starting study treatment * serious acute or chronic illness or recent history of significant cardiac abnormality * previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of egfr and pdgfr

Keywords: lung neoplasms
effect of gemcabene on the pharmacokinetics of atorvastatin in healthy volunteers

Conditions: Hypercholesteremia

Summary: the purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg


Eligibility criteria:
inclusion criteria: * males and females * 18-65 years of age * good health as determined by medical history, physical examination, vital signs, ecg, and clinical laboratory measurements; * body weight 45 kg or greater, with a body mass index (bmi) ≤ 35 kg/m² (weight \[kg\]/height\[meters\]²) exclusion criteria: * if female, of childbearing potential or lactation * history of significant adverse reaction to any lipid-lowering agent

Keywords: pharmacokinetics lipid regulator
safety, tolerability, and efficacy of gs-4997 alone or in combination with simtuzumab (sim) in adults with nonalcoholic steatohepatitis (nash) and fibrosis stages f2-f3

Conditions: Non-Alcoholic Steatohepatitis (NASH)

Summary: the primary objective of this study is to evaluate the safety and tolerability of gs-4997 (selonsertib \[sel\]) alone or in combination with simtuzumab (sim) in adults with nonalcoholic steatohepatitis (nash) and fibrosis stages f2-f3. participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.


Eligibility criteria:
key inclusion criteria: * males and non-pregnant, non-lactating females * evidence of nash with fibrosis on biopsy key exclusion criteria: * cirrhosis of the liver (e.g. brunt/kleiner score of f4) * other causes of liver disease including viral hepatitis and alcoholic liver disease * any history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding * history of liver transplantation * alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1 oz/30 ml of alcohol is present in 1 12 oz/360 ml beer, 1 4 oz/120 ml glass of wine, and a 1 oz/30 ml measure of 40% proof alcohol) note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: gs-4997 non-alcoholic fatty liver disease (nafld) fibrosis simtuzumab (sim) apoptosis signal-regulating kinase 1 ask1 inhibitor
impact of statin therapy on adaptations to aerobic exercise

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

high cholesterol and cardiovascular disease (cvd) is currently prevented and treated with statin therapy. statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase with dose and duration of statin use. statins may also change the ability to exercise. this study is testing how different doses of a statin, lipitor, affect muscle health and exercise. the doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol. this study is expected to last about 14 weeks.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 25-43 kg\^m2 * sedentary (less than 150 min of physical activity/week during last 6 months) * weight stable (no more than 5% change in body weight the previous 3 months) * \>5% risk for a cardiovascular event in the next 10 years according to the 2013 american college of cardiology/american heart association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(triglycerides ≥ 150 mg/dl; hdl ≤ 40 mg/dl; glucose ≥ 100mg/dl; waist circumference ≥ 102cm for males, 88cm for females; blood pressure: ≥ 130mmhg systolic and/or 85mmhg diastolic or being treated for hypertension). * stable doses of medications for 90 days * willing to stop all nonsteroidal antiinflammatory drugs (nsaids) and aspirin for 7 days prior to muscle biopsy exclusion criteria: * smoking * use of statins in the last 6 months * use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil) * diagnosis of chronic diseases including cvd, diabetes, other metabolic diseases (e.g., thyroid), cancer, hiv, or acquired immunodeficiency syndrome * history of abnormal bleeding problems * currently taking (within the last 10 days) anti-platelet medication (plavix), warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications * \>2 fold upper normal limit (unl) for alanine aminotransferase (alt) or creatinine * women who are pregnant or breastfeeding * individuals with polymorphisms known to be associated with susceptibility for statin induced myopathies (tested at screening) * currently enrolled in another research study

Keywords: high cholesterol exercise statins
trans-rectal ultrasound-guided (trus) adverse events

Conditions: Prostate Cancer

Summary: the goal of this study is to identify any side effects caused by the implanting of markers via the rectum. the investigators will also try to determine if any other factors (such as the position of the markers) influence the risk of side effects. the study procedures consist of two questionnaires:the first will be completed immediately after the marker implantation and the second questionnaire will be completed during your radiotherapy planning.

precise localisation of target organs has become increasingly important with the routine use of steep dose gradients from conformal and intensity modulated radiotherapy. this is particularly challenging when soft tissue target organs, such as the prostate, displace relative to bony anatomy. although novel imaging techniques are being developed for the direct visualisation of such soft tissue structures, contrast and image quality is currently limited. however, the use of radio-opaque intra-prostatic fiducial markers(ipm) during high dose radiotherapy has proven very effective in terms of improving accuracy, and decreasing toxicity.

Eligibility criteria:
inclusion criteria: * have biopsy confirmed prostate cancer (any risk category) * have 3 intra-prostatic markers inserted at pmh prior to radiotherapy * be willing to provide written informed consent * be willing to complete the adverse event questionnaires

Keywords: intra-prostate markers transrectal ultrasound prostate cancer patients